Label: PSODEX PSORIASIS CREAM INTENSIVE THERAPY- coal tar cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 12, 2021

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  • Drug Facts

  • Active ingredient

    Coal Tar 1%

    Purpose

    Psoriasis cream

  • Use

    Controls the symptoms of psoriasis

  • Warnings

    For external use only

    When using this product

    • Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn up to 24 hours after application.

    Do not use

    • For prolonged periods of time without consulting a doctor.
    • In or around the rectum or in the genital area or groin except on the advice of a doctor.
    • With other forms of psoriasis therapy such as ultraviolet radiation or prescription drugs unless directed to by a doctor.

    Ask a doctor before use if 

    condition covers a large area of the body

    Stop use and ask a doctor if

    condition worsens or does not improve after regular use of this product as directed.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Apply to affected areas one to four times daily or as directed by a doctor.

  • Other information

    Store at controlled room temperature 15°-30°C (59°-86°F)

  • Inactive ingredients

    Allantoin, Aloe Barbadensis Leaf Extract, Borage Seed Oil, Butyrospermum Parkii (Shea) Butter, Caprylic Capric Triglyceride, Caprylyl Glycol, Centella Asiatica Whole Extract, Cetearyl Alcohol, Cetearyl Olivate, Curcuma Longa Extract, D -Camphor Natural, D-Panthenol, Distilled Water, Ethylhexylglycerin, Frankincense Oil, Fumaria Officina is Extract, Genistein, Glycyrrhiza Glabra (Licorice) Root Extract, Mentha Piperita Leaf Extract, Pumpkin Seed Oil, Rosemary Leaf Oil, Salicylic Acid, Sorbitan Olivate, Stearic Acid, Tea Tree Leaf Oil, Vegetable Glycerin, Vitamin B3, Vitamin E, Zinc Acetate.

  • Questions or Comments?

    1-844-PSODEXUSA info@psodexusa.com

  • Package Labeling:

    Bottle.3

  • INGREDIENTS AND APPEARANCE
    PSODEX PSORIASIS CREAM INTENSIVE THERAPY 
    coal tar cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73503-006
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    COAL TAR (UNII: R533ESO2EC) (COAL TAR - UNII:R533ESO2EC) COAL TAR10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    BORAGE SEED OIL (UNII: F8XAG1755S)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    TURMERIC (UNII: 856YO1Z64F)  
    DEXPANTHENOL (UNII: 1O6C93RI7Z)  
    WATER (UNII: 059QF0KO0R)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FRANKINCENSE OIL (UNII: 67ZYA5T02K)  
    GENISTEIN (UNII: DH2M523P0H)  
    GLYCYRRHIZA GLABRA (UNII: 2788Z9758H)  
    PUMPKIN SEED OIL (UNII: 6E5QR5USSP)  
    ROSEMARY OIL (UNII: 8LGU7VM393)  
    SALICYLIC ACID (UNII: O414PZ4LPZ)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    NIACIN (UNII: 2679MF687A)  
    .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
    ZINC ACETATE (UNII: FM5526K07A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73503-006-011 in 1 BOX03/01/2021
    1100 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart358H03/01/2021
    Labeler - Psodex USA Inc. (076051073)
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